Catheter-Based Mitral Valve Leaflet Augmentation
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Solution Overview
Problem
Current treatments for mitral valve insufficiency, such as open-heart surgery, are complex, risky, and have high failure rates, with complications including increased risk of infection and stroke, and often require lifelong anticoagulation, making them unsuitable for all but severe cases.
Innovation Solution
A minimally invasive method involving a catheter-based procedure to pierce and dilate the mitral valve leaflets, allowing them to stretch and improve coaptation, using a dilation brace to maintain the leaflet area and prevent blood flow through the cuts, thereby enhancing valve function without the need for open-heart surgery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open-heart surgery is performed to treat mitral valve insufficiency, then valve function can be improved, but the procedure becomes complex and risky with high failure rates
Solution Approach 1:
The patent replaces the mechanical open-heart surgical system with a catheter-based delivery system that uses a cutting element and dilation component to achieve valve leaflet modification through minimally invasive access, thereby reducing procedural complexity and risk while maintaining therapeutic effectiveness
Solution Approach 2:
The patent employs nested components where the cutting element is delivered within a catheter, which is then replaced by a dilation component that is also delivered within the same catheter system. This nested delivery approach simplifies the overall procedure by using a single access route and reduces the complexity associated with multiple surgical incisions and device implantations
2Reliability
If open-heart surgery is performed to treat mitral valve insufficiency, then valve function can be improved, but the risk of complications such as infection and stroke increases
Solution Approach 1:
The patent replaces open-heart surgery with a catheter-based minimally invasive procedure, thereby avoiding large incisions, sternotomy, and cardiopulmonary bypass that are associated with high risks of infection, stroke, and other complications. The catheter approach uses small percutaneous access points that significantly reduce these harmful effects
Solution Approach 2:
The patent introduces a catheter as an intermediary device that delivers the cutting and dilation functions through a controlled, steerable shaft with radiopaque markers for visualization. This intermediary approach allows precise delivery of therapeutic action while isolating the patient from the harmful effects of open surgical exposure
3Reliability
If open-heart surgery is performed to treat mitral valve insufficiency, then valve function can be improved, but lifelong anticoagulation is required
Solution Approach 1:
The patent replaces surgical valve replacement or repair that requires mechanical prosthetics with a biologic leaflet modification approach. By using a catheter-delivered cutting and dilation system to modify the patient's own leaflet tissue, the procedure avoids the need for mechanical valves that would require lifelong anticoagulation therapy
4Object-affected harmful factors
If catheter-based procedure is used to pierce and dilate mitral valve leaflets, then the procedure becomes minimally invasive with fewer complications, but the leaflet structure must be carefully modified to improve coaptation
Solution Approach 1:
The patent replaces complex surgical techniques for leaflet modification with a catheter-based cutting and dilation system that provides precise control through a flexible shaft with radiopaque markers. This allows accurate positioning and modification of the leaflet tissue with minimal invasiveness
Solution Approach 2:
The patent modifies the physical parameters of the leaflet tissue by creating controlled cuts and then dilating the tissue to increase its surface area. This changes the geometric parameters of the leaflet to improve coaptation depth and valve function while maintaining the natural biologic material
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This approach safely and quickly augments the mitral valve leaflets, reducing the risk of complications, allowing for earlier intervention in mild cases, and potentially reversing cardiac remodeling, while providing a durable solution with fewer post-procedure care requirements compared to traditional methods.
Implementation Method 1
piercing a cardiac leaflet to produce a hole
Implementation Method 2
placing a dilation component in the hole; dilating the hole by activating the dilation component
Data Source
AI summary
Methods and devices for augmenting an atrioventricular valve leaflet is disclosed. A method according to an exemplary embodiment includes piercing a leaflet of the valve to at least a portion of the leaflet's thickness to form a pierced section; and extending the leaflet using said pierced section. A device according to an exemplary embodiment of the invention includes a catheter comprising: a longitudinal tube having a lumen; and a cutting element extendable from the lumen. The cutting element is adapted for forming a limited cut in an atrioventricular valve. A device according to another exemplary embodiment of the invention includes a catheter comprising a longitudinal tube having a lumen; a cutting element extendable from the lumen and adapted for forming a cut in a leaflet of an atrioventricular valve; and a frame, configured to attach to the leaflet and stay attached to the leaflet when the heart beats.